Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 33496 |
|---|---|
| 2: Name of authorisation holder | VECTURA LIMITED |
| 3: Address(es) of manufacturing site(s) |
VECTURA LIMITED, 1-6 PROSPECT WEST, CHIPPENHAM, SN14 6FH, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | VECTURA LIMITED, UNIT 1-6, PROSPECT WEST, BUMPERS WAY, BUMPERS FARM, CHIPPENHAM, SN14 6FH, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 04/11/2021 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
VECTURA LIMITED, 1-6 PROSPECT WEST, CHIPPENHAM, SN14 6FH, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell Special Requirements Substance with Hormonal Activity and Controlled Drugs |
| [ 1.2.1.15 ] Other non-sterile medicinal products DPI and Aerosols (Including filling primary container and Substance with Hormonal Activity and Contr |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.15 ] Other non-sterile medicinal products DPI and Aerosols (Including filling primary container and Substance with Hormonal Activity and Contr |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.3 ] Chemical/Physical |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.5 ] Biotechnology products |